EFFEXOR XR (venlafaxine hydrochloride)
Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for use in adult patients. It is approved for the treatment of major depressive disorder and generalized anxiety disorder. Additionally, the medication is used to manage social anxiety disorder and panic disorder in the adult population.
How EFFEXOR XR Works
The exact mechanism of venlafaxine in treating these conditions is not fully understood, but it is believed to be related to the potentiation of neurotransmitters in the central nervous system. The drug works by inhibiting the reuptake of serotonin and norepinephrine. By blocking this reabsorption, the medication increases the activity of these chemicals to produce its therapeutic effects.
Details
- Status
- Prescription
- First Approved
- 1997-10-20
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
EFFEXOR XR Approval History
What EFFEXOR XR Treats
4 indicationsEFFEXOR XR is approved for 4 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Social Anxiety Disorder
- Panic Disorder
EFFEXOR XR Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Effexor XR is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information f...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Effexor XR is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thoughts and behavior in pediatric patients and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). • Effexor XR is not approved for use in pediatric patients ( 8.4 ).
EFFEXOR XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00878748 | 0600X1-4434 | Ph 4 | withdrawn | Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EFFEXOR XR FDA Label Details
Indications & Usage
FDA Label (PDF)EFFEXOR XR is indicated for the treatment of Major Depressive Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.